BOXED WARNING
id: bcfb05e6-1db9-4268-ae36-d048596b13e4
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause
injury and even death to the developing fetus. When pregnancy is detected, Lisinopril tablet should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
DESCRIPTION
id: 781c20ce-0ee7-4dda-ba41-fbefd3606827
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3- phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5.2H2O and its structural formula is:
Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol.
Lisinopril tablet is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration.
Inactive Ingredients:
2.5 mg, 5 mg, 10 mg tablets – dibasic calcium phosphate dihydrate, povidone, pregelatinized starch, mannitol, colloidal silicon dioxide, corn starch, magnesium stearate.
20 mg, 30 mg, 40 mg tablets – dibasic calcium phosphate dihydrate, povidone, pregelatinized starch, mannitol, colloidal silicon dioxide, corn starch, magnesium stearate, ferric oxide yellow (for 20 mg), ferric oxide red (for 30 mg) and ferric oxide brown (for 40 mg).
INDICATIONS AND USAGE
id: 80358d26-a873-4c9b-b804-cac0638a3e21
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Hypertension
Lisinopril tablet is indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents.
Heart Failure
Lisinopril tablet is indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis.
Acute Myocardial Infarction
Lisinopril tablet is indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta blockers.
In using Lisinopril tablet, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that Lisinopril tablet does not have a similar risk. (See WARNINGS.)
In considering the use of Lisinopril tablet, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients (see WARNINGS, Anaphylactoid and Possibly Related Reactions).
CONTRAINDICATIONS
id: e1627d25-8f6a-45cf-a964-9e595c97022f
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Lisinopril tablet is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema.
ADVERSE REACTIONS
id: 212dbcf6-367e-405f-834a-b05272575976
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Lisinopril tablet has been found to be generally well tolerated in controlled clinical trials involving 1969 patients with hypertension or heart failure. For the most part, adverse experiences were mild and transient.
Hypertension
In clinical trials in patients with hypertension treated with Lisinopril tablet, discontinuation of therapy due to clinical adverse experiences occurred in 5.7% of patients. The overall frequency of adverse experiences could not be related to total daily dosage within the recommended therapeutic dosage range.
For adverse experiences occurring in greater than 1% of patients with hypertension treated with Lisinopril tablet or Lisinopril tablet plus hydrochlorothiazide in controlled clinical trials, and more frequently with Lisinopril tablet and/or Lisinopril tablet plus hydrochlorothiazide than placebo, comparative incidence data are listed in the table below:
PERCENT OF PATIENTS IN CONTROLLED STUDIES
|
|
Lisinopril tablet(n=1349)Incidence (discontinuation)
|
Lisinopril tablet/ Hydrochlorothiazide (n=629)Incidence (discontinuation)
|
PLACEBO(n=207)
Incidence (discontinuation)
|
| Body as a Whole
|
|
|
|
| Fatigue
|
2.5 (0.3)
|
4.0 (0.5)
|
1.0 (0.0)
|
| Asthenia
|
1.3 (0.5)
|
2.1 (0.2)
|
1.0 (0.0)
|
| Orthostatic Effects
|
1.2 (0.0)
|
3.5 (0.2)
|
1.0 (0.0)
|
| Cardiovascular
|
|
|
|
| Hypotension
|
1.2 (0.5)
|
1.6 (0.5)
|
0.5 (0.5)
|
| Digestive
|
|
|
|
| Diarrhea
|
2.7 (0.2)
|
2.7 (0.3)
|
2.4 (0.0)
|
| Nausea
|
2.0 (0.4)
|
2.5 (0.2)
|
2.4 (0.0)
|
| Vomiting
|
1.1 (0.2)
|
1.4 (0.1)
|
0.5 (0.0)
|
| Dyspepsia
|
0.9 (0.0)
|
1.9 (0.0)
|
0.0 (0.0)
|
| Musculoskeletal
|
|
|
|
| Muscle Cramps
|
0.5 (0.0)
|
2.9 (0.8)
|
0.5 (0.0)
|
| Nervous/Psychiatric
|
|
|
|
| Headache
|
5.7 (0.2)
|
4.5 (0.5)
|
1.9 (0.0)
|
| Dizziness
|
5.4 (0.4)
|
9.2 (1.0)
|
1.9 (0.0)
|
| Paresthesia
|
0.8 (0.1)
|
2.1 (0.2)
|
0.0 (0.0)
|
| Decreased Libido
|
0.4 (0.1)
|
1.3 (0.1)
|
0.0 (0.0)
|
| Vertigo
|
0.2 (0.1)
|
1.1 (0.2)
|
0.0 (0.0)
|
| Respiratory
|
|
|
|
| Cough
|
3.5 (0.7)
|
4.6 (0.8)
|
1.0 (0.0)
|
| Upper Respiratory Infection
|
2.1 (0.1)
|
2.7 (0.1)
|
0.0 (0.0)
|
| Common Cold
|
1.1 (0.1)
|
1.3 (0.1)
|
0.0 (0.0)
|
| Nasal Congestion
|
0.4 (0.1)
|
1.3 (0.1)
|
0.0 (0.0)
|
| Influenza
|
0.3 (0.1)
|
1.1 (0.1)
|
0.0 (0.0)
|
| Skin
|
|
|
|
| Rash
|
1.3 (0.4)
|
1.6 (0.2)
|
0.5 (0.5)
|
| Urogenital
|
|
|
|
| Impotence
|
1.0 (0.4)
|
1.6 (0.5)
|
0.0 (0.0)
|
Chest pain and back pain were also seen, but were more common on placebo than Lisinopril tablet.
Heart Failure
In patients with heart failure treated with Lisinopril tablet for up to four years, discontinuation of therapy due to clinical adverse experiences occurred in 11.0% of patients. In controlled studies in patients with heart failure, therapy was discontinued in 8.1% of patients treated with Lisinopril tablet for 12 weeks, compared to 7.7% of patients treated with placebo for 12 weeks.
The following table lists those adverse experiences which occurred in greater than 1% of patients with heart failure treated with Lisinopril tablet or placebo for up to 12 weeks in controlled clinical trials, and more frequently on Lisinopril tablet than placebo.
|
|
Controlled Trials
|
|
|
Lisinopril tablet
(n=407)
Incidence (discontinuation)
12 weeks
|
Placebo
(n=155)
Incidence(discontinuation)
12 weeks
|
| Body as a Whole
|
|
|
| Chest Pain
|
3.4 (0.2)
|
1.3 (0.0)
|
| Abdominal Pain
|
2.2 (0.7)
|
1.9 (0.0)
|
| Cardiovascular
|
|
|
| Hypotension
|
4.4 (1.7)
|
0.6 (0.6)
|
| Digestive
|
|
|
| Diarrhea
|
3.7 (0.5)
|
1.9 (0.0)
|
| Nervous/Psychiatric
|
|
|
| Dizziness
|
11.8 (1.2)
|
4.5 (1.3)
|
| Headache
|
4.4 (0.2)
|
3.9 (0.0)
|
| Respiratory
|
|
|
| Upper Respiratory Infection
|
1.5 (0.0)
|
1.3 (0.0)
|
| Skin
|
|
|
| Rash
|
1.7 (0.5)
|
0.6 (0.6)
|
Also observed at >1% with Lisinopril tablet but more frequent or as frequent on placebo than Lisinopril tablet in controlled trials were asthenia, angina pectoris, nausea, dyspnea, cough, and pruritus.
Worsening of heart failure, anorexia, increased salivation, muscle cramps, back pain, myalgia, depression, chest sound abnormalities, and pulmonary edema were also seen in controlled clinical trials, but were more common on placebo than Lisinopril tablet.
In the two-dose ATLAS trial in heart failure patients, withdrawals due to adverse events were not different between the low and high groups, either in total number of discontinuation (17-18%) or in rare specific events (<1%). The following adverse events, mostly related to ACE inhibition, were reported more commonly in the high dose group:
|
*NPN = non-protein nitrogen
|
% of patients
Events
|
High Dose
(N=1568)
|
Low dose (N=1596)
|
|
|
|
|
| Dizziness
|
18.9
|
12.1
|
| Hypotension
|
10.8
|
6.7
|
| Creatinine increased
|
9.9
|
7.0
|
| Hyperkalemia
|
6.4
|
3.5
|
| NPN* increased
|
9.2
|
6.5
|
| Syncope
|
7.0
|
5.1
|
Acute Myocardial Infarction
In the GISSI-3 trial, in patients treated with Lisinopril tablet for six weeks following acute myocardial infarction, discontinuation of therapy occurred in 17.6% of patients.
Patients treated with Lisinopril tablet had a significantly higher incidence of hypotension and renal dysfunction compared with patients not taking Lisinopril tablet.
In the GISSI-3 trial, hypotension (9.7%), renal dysfunction (2.0%), cough (0.5%), post infarction angina (0.3%), skin rash and generalized edema (0.01%), and angioedema (0.01%) resulted in withdrawal of treatment. In elderly patients treated with Lisinopril tablet, discontinuation due to renal dysfunction was 4.2%.
Other clinical adverse experiences occurring in 0.3% to 1.0% of patients with hypertension or heart failure treated with Lisinopril tablet in controlled clinical trials and rarer, serious, possibly drug-related events reported in uncontrolled studies or marketing experience are listed below, and within each category are in order of decreasing severity:
Body as a Whole: Anaphylactoid reactions (see WARNINGS, Anaphylactoid and Possibly Related Reactions), syncope, orthostatic effects, chest discomfort, pain, pelvic pain, flank pain, edema, facial edema, virus infection, fever, chills, malaise.
Cardiovascular: Cardiac arrest; myocardial infarction or cerebrovascular accident possibly secondary to excessive hypotension in high risk patients (see WARNINGS, Hypotension); pulmonary embolism and infarction, arrhythmias (including ventricular tachycardia, atrial tachycardia, atrial fibrillation, bradycardia and premature ventricular contractions), palpitations, transient ischemic attacks, paroxysmal nocturnal dyspnea, orthostatic hypotension, decreased blood pressure, peripheral edema, vasculitis.
Digestive: Pancreatitis, hepatitis (hepatocellular or cholestatic jaundice) (see WARNINGS, Hepatic Failure), vomiting, gastritis, dyspepsia, heartburn, gastrointestinal cramps, constipation, flatulence, dry mouth.
Hematologic: Rare cases of bone marrow depression, hemolytic anemia, leukopenia/ neutropenia and thrombocytopenia.
Endocrine: Diabetes mellitus.
Metabolic: Weight loss, dehydration, fluid overload, gout, weight gain. Cases of hypoglycemia in diabetic patients on oral antidiabetic agents or insulin have been reported in post-marketing experience (See PRECAUTIONS, Drug Interactions).
Musculoskeletal: Arthritis, arthralgia, neck pain, hip pain, low back pain, joint pain, leg pain, knee pain, shoulder pain, arm pain, lumbago.
Nervous System/Psychiatric: Stroke, ataxia, memory impairment, tremor, peripheral neuropathy (e.g., dysesthesia), spasm, paresthesia, confusion, insomnia, somnolence, hypersomnia, irritability, nervousness and mood alterations (including depressive symptoms).
Respiratory System: Malignant lung neoplasms, hemoptysis, pulmonary infiltrates, bronchospasm, asthma, pleural effusion, pneumonia, eosinophilic pneumonitis, bronchitis, wheezing, orthopnea, painful respiration, epistaxis, laryngitis, sinusitis, pharyngeal pain, pharyngitis, rhinitis, rhinorrhea.
Skin: Urticaria, alopecia, herpes zoster, photosensitivity, skin lesions, skin infections, pemphigus, erythema, flushing, diaphoresis, cutaneous pseudolymphoma. Other severe skin reactions have been reported rarely, including toxic epidermal necrolysis and Stevens-Johnson syndrome; causal relationship has not been established.
Special Senses: Visual loss, diplopia, blurred vision, tinnitus, photophobia, taste disturbances.
Urogenital System: Acute renal failure, oliguria, anuria, uremia, progressive azotemia, renal dysfunction (see PRECAUTIONS and DOSAGE AND ADMINISTRATION), pyelonephritis, dysuria, urinary tract infection, breast pain.
Miscellaneous: A symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia, fever, vasculitis, eosinophilia and leukocytosis. Rash, photosensitivity or other dermatological manifestations may occur alone or in combination with these symptoms.
Angioedema: Angioedema has been reported in patients receiving Lisinopril tablet (0.1%) with an incidence higher in Black than in non-Black patients. Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis and/or larynx occurs, treatment with Lisinopril tablet should be discontinued and appropriate therapy instituted immediately (See WARNINGS).
In rare cases, intestinal angioedema has been reported in post marketing experience.
Hypotension: In hypertensive patients, hypotension occurred in 1.2% and syncope occurred in 0.1% of patients with an incidence higher in Black than in non-Black patients. Hypotension or syncope was a cause of discontinuation of therapy in 0.5% of hypertensive patients. In patients with heart failure, hypotension occurred in 5.3% and syncope occurred in 1.8% of patients. These adverse experiences were possibly dose-related (see above data from ATLAS Trial) and caused discontinuation of therapy in 1.8% of these patients in the symptomatic trials. In patients treated with Lisinopril tablet for six weeks after acute myocardial infarction, hypotension (systolic blood pressure ≤100 mmHg) resulted in discontinuation of therapy in 9.7% of the patients (See WARNINGS).
Fetal/Neonatal Morbidity and Mortality: See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
Cough: See PRECAUTIONS – Cough
Pediatric Patients: No relevant differences between the adverse experience profile for pediatric patients and that previously reported for adult patients were identified.
Clinical Laboratory Findings
Serum Electrolytes: Hyperkalemia (See PRECAUTIONS), hyponatremia.
Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 2.0% of patients with essential hypertension treated with Lisinopril tablet alone. Increases were more common in patients receiving concomitant diuretics and in patients with renal artery stenosis (See PRECAUTIONS). Reversible minor increases in blood urea nitrogen and serum creatinine were observed in approximately 11.6% of patients with heart failure on concomitant diuretic therapy. Frequently, these abnormalities resolved when the dosage of the diuretic was decreased.
Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.4 g% and 1.3 vol%, respectively) occurred frequently in patients treated with Lisinopril tablet but were rarely of clinical importance in patients without some other cause of anemia. In clinical trials, less than 0.1% of patients discontinued therapy due to anemia. Hemolytic anemia has been reported; a causal relationship to lisinopril cannot be excluded.
Liver Function Tests: Rarely, elevations of liver enzymes and/or serum bilirubin have occurred. (See WARNINGS, Hepatic Failure).
In hypertensive patients, 2.0% discontinued therapy due to laboratory adverse experiences, principally elevations in blood urea nitrogen (0.6%), serum creatinine (0.5%) and serum potassium (0.4%).
In the heart failure trials, 3.4% of patients discontinued therapy due to laboratory adverse experiences; 1.8% due to elevations in blood urea nitrogen and/or creatinine and 0.6% due to elevations in serum potassium.
In the myocardial infarction trial, 2.0% of patients receiving Lisinopril tablet discontinued therapy due to renal dysfunction (increasing creatinine concentration to over 3 mg/dL or a doubling or more of the baseline serum creatinine concentration); less than 1.0% of patients discontinued therapy due to other laboratory adverse experiences: 0.1% with hyperkalemia and less than 0.1% with hepatic enzyme alterations.
OVERDOSAGE
id: 6113e736-1046-44f2-8a0c-4dd47e41aba6
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Following a single oral dose of 20 g/kg no lethality occurred in rats, and death occurred in one of 20 mice receiving the same dose. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution.
Lisinopril can be removed by hemodialysis. (See WARNINGS, Anaphylactoid Reactions During Membrane Exposure.)
DOSAGE AND ADMINISTRATION
id: d164d85b-15e0-49c1-8709-8917304e309d
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Hypertension
Initial Therapy: In patients with uncomplicated essential hypertension not on diuretic therapy, the recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered in a single daily dose. The antihypertensive effect may diminish toward the end of the dosing interval regardless of the administered dose, but most commonly with a dose of 10 mg daily. This can be evaluated by measuring blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours. If it is not, an increase in dose should be considered. Doses up to 80 mg have been used but do not appear to give greater effect. If blood pressure is not controlled with Lisinopril tablet alone, a low dose of a diuretic may be added. Hydrochlorothiazide, 12.5 mg has been shown to provide an additive effect. After the addition of a diuretic, it may be possible to reduce the dose of Lisinopril tablet.
Diuretic Treated Patients: In hypertensive patients who are currently being treated with a diuretic, symptomatic hypotension may occur occasionally following the initial dose of Lisinopril tablet. The diuretic should be discontinued, if possible, for two to three days before beginning therapy with Lisinopril tablet to reduce the likelihood of hypotension. (See WARNINGS.) The dosage of Lisinopril tablet should be adjusted according to blood pressure response. If the patient”s blood pressure is not controlled with Lisinopril tablet alone, diuretic therapy may be resumed as described above.
If the diuretic cannot be discontinued, an initial dose of 5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS and PRECAUTIONS, Drug Interactions.)
Concomitant administration of Lisinopril tablet with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium. (See PRECAUTIONS.)
Dosage Adjustment in Renal Impairment: The usual dose of Lisinopril tablet (10 mg) is recommended for patients with creatinine clearance >30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance ≥10 mL/min ≤30 mL/min (serum creatinine ≥3 mg/dL), the first dose is 5 mg once daily. For patients with creatinine clearance <10 mL/min (usually on hemodialysis) the recommended initial dose is 2.5 mg. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.
|
* See WARNINGS, Anaphylactoid Reactions During Membrane Exposure.
|
|
** Dosage or dosing interval should be adjusted depending on the blood pressure response.
|
| Renal Status
|
Creatinine Clearance
mL/min
|
Initial Dose
mg/day
|
Normal Renal Function
to Mild Impairment
|
>30
|
10
|
| Moderate to Severe Impairment
|
≥10 ≤30
|
5
|
| Dialysis Patients*
|
<10
|
2.5**
|
Heart FailureLisinopril tablet is indicated as adjunctive therapy with diuretics and (usually) digitalis. The recommended starting dose is 5 mg once a day. When initiating treatment with lisinopril in patients with heart failure, the initial dose should be administered under medical observation, especially in those patients with low blood pressure (systolic blood pressure below 100 mmHg). The mean peak blood pressure lowering occurs six to eight hours after dosing. Observation should continue until blood pressure is stable. The concomitant diuretic dose should be reduced, if possible, to help minimize hypovolemia which may contribute to hypotension. (See WARNINGS and PRECAUTIONS, Drug Interactions.) The appearance of hypotension after the initial dose of Lisinopril tablet does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
The usual effective dosage range is 5 to 40 mg per day administered as a single daily dose. The dose of Lisinopril tablet can be increased by increments of no greater than 10 mg, at intervals of no less than 2 weeks to the highest tolerated dose, up to a maximum of 40 mg daily. Dose adjustment should be based on the clinical response of individual patients.
Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia: In patients with heart failure who have hyponatremia (serum sodium <130 mEq/L) or moderate to severe renal impairment (creatinine clearance ≤30 mL/min or serum creatinine >3 mg/dL), therapy with Lisinopril tablet should be initiated at a dose of 2.5 mg once a day under close medical supervision. (See WARNINGS and PRECAUTIONS, Drug Interactions.)
Acute Myocardial Infarction
In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, the first dose of Lisinopril tablet is 5 mg given orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg of Lisinopril tablet once daily. Dosing should continue for six weeks. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin, and beta-blockers.
Patients with a low systolic blood pressure (≤120 mmHg) when treatment is started or during the first 3 days after the infarct should be given a lower 2.5 mg oral dose of Lisinopril tablet (see WARNINGS). If hypotension occurs (systolic blood pressure ≤100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure <90 mmHg for more than 1 hour) Lisinopril tablet should be withdrawn. For patients who develop symptoms of heart failure, see DOSAGE AND ADMINISTRATION, Heart Failure.
Dosage Adjustment in Patients With Myocardial Infarction with Renal Impairment: In acute myocardial infarction, treatment with Lisinopril tablet should be initiated with caution in patients with evidence of renal dysfunction, defined as serum creatinine concentration exceeding 2 mg/dL. No evaluation of dosing adjustments in myocardial infarction patients with severe renal impairment has been performed
Use in Elderly
In general, the clinical response was similar in younger and older patients given similar doses of Lisinopril tablet. Pharmacokinetic studies, however indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients, so that dosage adjustments should be made with particular caution.
Pediatric Hypertensive Patients ≥6 Years of age
The usual recommended starting dose is 0.07 mg/kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response. Doses above 0.61 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients. (See CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism and Pharmacodynamics and Clinical Effects.)
Lisinopril tablet is not recommend in pediatric patients <6 years or in pediatric patients with glomerular filtration rate <30 mL/min/1.73 min2 (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism and Pharmacodynamics and Clinical Effects and PRECAUTIONS).
Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension): Add 10 mL of Purified Water USP to a polyethylene terephthalate (PET) bottle containing ten 20 mg tablets of Lisinopril tablet and shake for at least one minute. Add 30 mL of Bicitra®† diluent and 160 mL of Ora Sweet SF™†† to the concentrate in the PET bottle and gently shake for several seconds to disperse the ingredients. The suspension should be stored at or below 250C (770F) and can be stored for up to four weeks. Shake the suspension before each use.
† Registered trademark of Alza Corporation
†† Trademark of Paddock Laboratories, Inc.
HOW SUPPLIED
id: 516ff3e5-4229-4dc8-a63a-48c4c4f9ffc7
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
2.5 mg Tablets, white to off-white, round biconvex uncoated tablets debossed with “W” on one side and other side plain.
(NDC 0615-7639-39) Blistercards of 30 tablets
(NDC 0615-7639-31) Blistercards of 31 tablets
5 mg Tablets, white to off-white, round biconvex uncoated tablets debossed with “W928” on one side and breakline on other side.
(NDC 0615-7640-39) Blistercards of 30 tablets
(NDC 0615-7640-31) Blistercards of 31 tablets
(NDC 0615-7640-05) Blistercards of 15 tablets
10 mg Tablets, white to off-white, round biconvex uncoated tablets debossed with “W929” on one side and other side plain.
(NDC 0615-7641-39) Blistercards of 30 tablets
(NDC 0615-7641-31) Blistercards of 31 tablets
(NDC 0615-7641-05) Blistercards of 15 tablets
20 mg Tablets, mottled light yellow, round biconvex uncoated tablets debossed with “W941” on one side and other side plain.
(NDC 0615-7642-39) Blistercards of 30 tablets
(NDC 0615-7642-31) Blistercards of 31 tablets
(NDC 0615-7642-05) Blistercards of 15 tablets
30 mg Tablets, mottled light red, round biconvex uncoated tablets debossed with “W953” on one side and other side plain.
(NDC 0615-7643-39) Bottles of 30 tablets
40 mg Tablets, mottled light brown, round biconvex uncoated tablets debossed with “W942” on one side and other side plain.
(NDC 0615-7644-39) Blistercards of 30 tablets
(NDC 0615-7644-31) Blistercards of 31 tablets
(NDC 0615-7644-05) Blistercards of 15 tablets
STORAGE AND HANDLING
id: d77e2add-e206-485d-9a98-a77859459f22
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7
Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.
*AN69 is a registered trademark of Hospal Ltd.
Manufactured by:
Wockhardt Limited
Mumbai, India.
Distributed by:
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054USA.
Rev.290709
PRINCIPAL DISPLAY PANEL 2.5mg
id: 1cbad874-fc29-4115-ad1b-ebaae79ce4b9
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPAL DISPLAY PANEL 5mg
id: 31787b28-9e49-4940-886e-8bfa40b92e7d
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPAL DISPLAY PANEL 10mg
id: 990f11b9-9eed-4c91-8e61-5b34c0d89562
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
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id: 75723020-3236-4b91-b684-424e17e8d45f
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
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id: ff437084-ac30-4ccc-bb85-b9e2aae859c7
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
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id: 509a3a41-155b-4acf-81fc-341ce9c0956d
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
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